INDICATIONS

Intracavernosal CAVERJECT may be a useful adjunct to other diagnostic tests in the diagnosis of erect ile dysfunct ion.

DOSAGE AND ADMINISTRATION

The dose of CAVERJECT should be individualized for each patient by careful
titration under supervision by the physician. In clinical studies, patients
were treated with CAVERJECT in doses ranging from 0.2 to 140 micrograms; however,
since 99% of patients received doses of 60 micrograms or less, doses of greater
than 60 micrograms are not recommended. In general, the lowest possible effective
dose should always be employed. In clinical studies, over 80% of patients experienced
an erection sufficient for sexual intercourse after intracavernosal injection
of CAVERJECT. A 1/2-inch, 27- to 30- gauge needle is generally recommended.

Initial Titration in Physician's Office

Erectile Dysfunction of Vasculogenic, Psychogenic, or Mixed Etiology.
Dosage titration should be initiated at 2.5 micrograms of alprostadil. If there
is a partial response, the dose may be increased by 2.5 micrograms to a dose
of 5 micrograms and then in increments of 5 to 10 micrograms, depending upon
erectile response, until the dose that produces an erection suitable for intercourse
and not exceeding a duration of 1 hour is reached. If there is no response to
the initial 2.5-microgram dose, the second dose may be increased to 7.5 micrograms,
followed by increments of 5 to 10 micrograms. The patient must stay in the physician's
office until complete detumescence occurs. If there is no response, then the
next higher dose may be given within 1 hour. If there is a response, then there
should be at least a 1-day interval before the next dose is given.

Erectile Dysfunction of Pure Neurogenic Etiology (Spinal Cord Injury).
Dosage titration should be initiated at 1.25 micrograms of alprostadil.
The dose may be increased by 1.25 micrograms to a dose of 2.5 micrograms, followed
by an increment of 2.5 micrograms to a dose of 5 micrograms, and then in 5-microgram
increments until the dose that produces an erection suitable for intercourse
and not exceeding a duration of 1 hour is reached. The patient must stay in
the physician's office until complete detumescence occurs. If there is no response,
then the next higher dose may be given within 1 hour. If there is a response,
then there should be at least a 1-day interval before the next dose is given.

The majority of patients (56%) in one clinical study involving 579 patients were titrated to doses of greater than 5 micrograms but less than or equal to 20 micrograms. The mean dose at the end of the titration phase was 17.8 micrograms of alprostadil.

Maintenance Therapy

The first injections of CAVERJECT must be done at the physician's office by
medically trained personnel. Self-injection therapy by the patient can be started
only after the patient is properly instructed and well trained in the self-injection
technique. The physician should make a careful assessment of the patient's skills
and competence with this procedure. The intracavernosal injection must be done
under sterile conditions. The site of injection is usually along the dorso-lateral
aspect of the proximal third of the penis. Visible veins should be avoided.
The side of the penis that is injected and the site of injection must be alternated;
the injection site must be cleansed with an alcohol swab.

The dose of CAVERJECT that is selected for self-injection treatment should
provide the patient with an erection that is satisfactory for sexual intercourse
and that is maintained for no longer than 1 hour. If the duration of erection
is longer than 1 hour, the dose of CAVERJECT should be reduced. Selfinjection
therapy for use at home should be initiated at the dose that was determined
in the physician's office; however, dose adjustment, if required (up to 57%
of patients in one clinical study), should be made only after consultation with
the physician. The dose should be adjusted in accordance with the titration
guidelines described above. The effectiveness of CAVERJECT for long-term use
of up to 6 months has been documented in an uncontrolled, self-injection study.
The mean dose of CAVERJECT at the end of 6 months was 20.7 micrograms in this
study.

Careful and cont inuous follow-up of the patient while in the self-injection
program must be exercised. This is especially true for the initial self-injections,
since adjustments in the dose of CAVERJECT may be needed. The recommended frequency
of injection is no more than 3 times weekly, with at least 24 hours between
each dose. The reconstituted vial of CAVERJECT is intended for single use only
and should be discarded after use. The user should be instructed in the proper
disposal of the syringe, needle, and vial.

While on self-injection treatment, it is recommended that the patient visit the prescribing physician's office every 3 months. At that time, the efficacy and safety of the therapy should be assessed, and the dose of CAVERJECT should be adjusted, if needed.

CAVERJECT as an Adjunct to the Diagnosis of Erectile Dysfunction

In the simplest diagnostic test for erectile dysfunction (pharmacologic testing),
patients are monitored for the occurrence of an erection after an intracavernosal
injection of CAVERJECT. Extensions of this testing are the use of CAVERJECT
as an adjunct to laboratory investigations, such as duplex or Doppler imaging,
133Xenon washout tests, radioisotope penogram, and penile arteriography, to
allow visualization and assessment of penile vasculature. For any of these tests,
a single dose of CAVERJECT that induces an erection with firm rigidity should
be used.

General Procedure for Solution Preparation

CAVERJECT is packaged in a 5-milliliter glass vial. Bacteriostatic water for
injection or sterile water, both preserved with benzyl alcohol 0.945% w/v, must
be used as the diluent for reconstitution. After reconst itut ion with 1 millili
ter of diluent, the volume of the resulting solution is 1.13 milliliters. One
millili ter of this solut ion will contain 5.4, 10.5, 20.5 or 41.1 micrograms
of alprostadil depending on vial strength, 172 milligrams of lactose, 47 micrograms
of sodium citrate and 8.4 milligrams of benzyl alcohol. The deliverable amount
of alprostadil is 5, 10, 20 or 40 micrograms per milliliter because approximately
0.4 microgram for the 5 microgram strength, 0.5 microgram for the 10 and 20
microgram strengths and 1.1 microgram for the 40 microgram strength is lost
due to adsorption to the vial and syringe. After reconstitution, the solution
of CAVERJECT should be used within 24 hours when stored at or below 25°C
(77°F) and not refrigerated or frozen. Parenteral drug products should be
inspected visually for particulate matter and discoloration prior to administration
whenever the solution and container permit.

HOW SUPPLIED

CAVERJECT is a dry lyophilized powder and is supplied in vials containing 6.15, 11.9, 23.2 or 46.4 micrograms of alprostadil for intracavernosal administration. Store the 5, 10 and 20 microgram strengths at or below 25°C (77°F).

Store the 40 microgram strength at 2° to 8°C (36° to 46°F)
until dispensed. After dispensing, the CAVERJECT 40 microgram strength may be
stored at or below 25°C (77°F) for 3 months or until expiration date,
whichever occurs first.

When reconstituted and used as directed, the deliverable amount of alprostadil is 5, 10, 20 or 40 micrograms, respectively. The reconstituted solution should be used within 24 hours when stored at or below 25°C (77°F) and not refrigerated or frozen. Only the accompanying diluent or bacteriostatic water for injection with benzyl alcohol should be used when reconstituting CAVERJECT. CAVERJECT is available in the following packages: